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Once the 4th Edition is published, redesigns and QMS updates will be far more costly.
Direct insights from someone in the development of IEC 60601-1, 4th Edition
Get an insiderโs view of the upcoming changes, their real-world impact, and how to prepare, from someone directly involved in developing the standard.
Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:
Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines
Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions
Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.
Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays
Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,
Leo Eisner, The60601Guy will be visiting London ๐ฌ๐ง๐ก๐ฐ in October. You have the chance to sit down with me, The60601Guy, have a cup a coffee or a beer and talk IEC60601, design for compliance, and standards that apply to your device. I have time slots open on 7, 8, and 11 of Oct. Or join me for a dinner on the 8 or 11 Oct.
Meet me in London – I want to hear from you the week of 7 Oct. These two hour slots are limited before they are gone, ๐ฏ๐ผ๐ผ๐ธ ๐ป๐ผ๐ ๐ผ๐ป ๐บ๐ ๐๐ฝ๐ฒ๐ฐ๐ถ๐ฎ๐น ๐ฐ๐ฎ๐น๐ฒ๐ป๐ฑ๐ฎ๐ฟ for ๐บ๐ ๐๐ผ๐ป๐ฑ๐ผ๐ป ๐๐ถ๐๐ถ๐. Iโd love to chat!
Free presentation in London ๐ฌ๐ง๐ก๐ฐ โ With Leo Eisner, The60601Guy, & Ian Sealey
๐ช๐ต๐ฎ๐โ๐ ๐ผ๐ป ๐๐ต๐ฒ ๐บ๐ฒ๐ป๐๐ฐ?
โข Some ๐ณ๐๐๐๐ฟ๐ฒ ๐ฟ๐ฒ๐พ๐๐ถ๐ฟ๐ฒ๐บ๐ฒ๐ป๐๐ of IEC60601-1 , 4th being considered you ๐ข๐๐ฎ ๐ฃ๐ค๐ฉ ๐๐ญ๐ฅ๐๐๐ฉ:
Gas Pathways,
Cleaning,
Disinfection,
AI/ML,
Voice Input/Output,
Adhesives for Applied Parts,
PPE,
and so much more….
โข IEC60601-1 , 4th Ed.
โข Applicable Standards
โข Future Proofing Test Plans